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Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Nova Scotia Health Authority.
Recruitment status was:  Recruiting
Information provided by:
Nova Scotia Health Authority Identifier:
First received: October 25, 2010
Last updated: June 29, 2011
Last verified: June 2011

Vascular epithelial growth factor (VEGF) plays a critical role in vessel growth and wound healing. Bevacizumab, a non specific VEGF inhibitor, has been successfully used for the treatment of eye diseases associated with neovascularization. The purpose of this randomized study is 1) to investigate the effects of intraoperative subtenon injection of bevacizumab on the outcomes of trabeculectomy surgery. 2) to measure plasma and aqueous levels of VEGF and assess its association with the outcomes of trabeculectomy surgery. Trabeculectomy surgery, where a small drainage canal is created at the front of the eye, is the most common glaucoma surgery performed worldwide. The goal of the surgery is to control intraocular pressure. Failure of this procedure is most commonly caused by excessive scarring of the surgical site. If scarring occurs, the drainage canal can close. By adding Bevacizumab at the time of surgery, wound healing may be slowed and surgical failure prevented.

The results of this study will be helpful in the future development of new more effective and safe surgical techniques for treatment of glaucoma.

Patients who have given informed consent are randomized into two groups. One group receives standard of care for trabeculectomy surgery and the other group receives standard of care plus an injection of Bevacizumab at the surgery site. Both groups have a one time collection of ocular fluid and a blood sample taken from a vein in the arm. After surgery, patients are seen by their study doctor six times in the following year. At these visits measurements are taken of their visual acuity, eye pressure and blood pressure. The doctor does a clinical exam and at months six and twelve photographs of the patients' eye are taken.

Condition Intervention Phase
Glaucoma Drug: Bevacizumab Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use of Vascular Endothelial Growth Factor Inhibitor, Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

Resource links provided by NLM:

Further study details as provided by Nova Scotia Health Authority:

Primary Outcome Measures:
  • post surgery IOP (Intra Ocular Pressure Measurement) [ Time Frame: one year post surgery ]

Secondary Outcome Measures:
  • bleb appearance [ Time Frame: one year post surgery ]
  • number of bleb needlings [ Time Frame: one year post surgery ]
  • number of glaucoma medications at 12 months postoperatively [ Time Frame: one year post surgery ]
  • eye complications [ Time Frame: one year post surgery ]
  • systemic complications [ Time Frame: one year post surgery ]
  • need for another glaucoma surgery to control glaucoma [ Time Frame: one year post surgery ]
  • postoperative visual acuity at 12 months [ Time Frame: 12 months post surgery ]

Estimated Enrollment: 60
Study Start Date: July 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard of care
standard of care for trabeculectomy surgery
Drug: Bevacizumab
single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery
Other Name: Avastin
Active Comparator: bevacizumab arm Drug: Bevacizumab
single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery
Other Name: Avastin


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • any type of glaucoma, except neovascular or inflammatory
  • patients requiring trabeculectomy or combined cataract surgery with trabeculectomy surgery

Exclusion Criteria:

  • younger than 30 years of age
  • previous ocular surgeries excepting cataract surgeries
  • patients who have had or present with intraocular inflammation
  • neovascular glaucoma
  • patients who are aphakic
  • diabetic retinopathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01229202

Contact: Lesya Shuba, MD, PhD 902 473-3410
Contact: Mimi Stanfield, BA 901 473-3236

Canada, Nova Scotia
CDHA Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Sponsors and Collaborators
Nova Scotia Health Authority
Principal Investigator: Lesya Shuba, MD PhD CDHA Halifax Nova Scotia Canada
  More Information

Responsible Party: Lesya Shuba MD FRCSC PhD, Capital District Health Authority, Halifax, Nova Scotia,Canada Identifier: NCT01229202     History of Changes
Other Study ID Numbers: CD-2007-331
Study First Received: October 25, 2010
Last Updated: June 29, 2011

Keywords provided by Nova Scotia Health Authority:
glaucoma surgery
Vascular Endothelial Growth Inhibitor

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Endothelial Growth Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents processed this record on September 19, 2017